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目的:制备鱼腥草壳聚糖滴眼液并建立质量控制方法。方法:以壳聚糖为增稠剂及增效剂,用新鱼腥草素钠为主药制备鱼腥草壳聚糖滴眼液,采用高效液相色谱法(HPLC法)测定制剂中新鱼腥草素钠的含量,依据《中国药典》2005年版对滴眼液进行质量控制。结果:所制备的鱼腥草壳聚糖滴眼液质量稳定,含量准确,平均回收率为98.4%,RSD=2.2(n=6)。结论:该制剂制备工艺简单,合理可行;质量控制方法准确、可靠。
Objective: To prepare Houttuynia Chitosan Eye Drops and to establish a quality control method. Methods: With chitosan as thickener and synergist, Houttuynia chinensis eye drops were prepared with new sodium houttuyfonate as the main drug, and the content of chondroitin sulfate was determined by high performance liquid chromatography (HPLC) Houttuyfonate sodium content, based on “Chinese Pharmacopoeia” 2005 edition of the eye drops for quality control. Results: The prepared Houttuynia chrysogenum eye drops had stable quality and accurate content with an average recovery of 98.4% and RSD = 2.2 (n = 6). Conclusion: The preparation process is simple, reasonable and feasible; quality control method is accurate and reliable.